dexamethasone

FDA Drug Profile — Dexamethasone, dexamethasone, MAXIDEX, Dexycu, Hemady

Drug Details

Generic Name
dexamethasone
Brand Names
Dexamethasone, dexamethasone, MAXIDEX, Dexycu, Hemady, OZURDEX, DEXTENZA
Application Number
ANDA088481
Sponsor
Alvogen Inc.
NDC Codes
24
Dosage Forms
TABLET, POWDER, IMPLANT, FOR SUSPENSION, INJECTION, SUSPENSION, INSERT
Routes
ORAL, OPHTHALMIC, INTRAOCULAR, INTRAVITREAL, INTRACANALICULAR
Active Ingredients
DEXAMETHASONE

Indications and Usage

1 INDICATIONS AND USAGE Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa. Ciprofloxacin and dexamethasone otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa . ( 1 )